To evaluate the safety and feasibility of non-invasive magnetic stimulation of the posterior tibial nerve using the EMKinetics LoFIT Pulse System for treating patients with documented overactive bladder.

The patient is pregnant or intends to become pregnant during the course of the study. (Patients becoming pregnant during the course of the study will immediately be terminated from the study.)

The patient has an active urinary tract infection.

Neurogenic bladder

Botox use in bladder or pelvic floor muscles in the past year

Pacemakers or implantable defibrillators

Primary complaint of stress urinary incontinence

Current vaginal infection

Current use of InterStim

Current use of Bion

Current use of TENS in the pelvic region, back or leg

Previously been treated with PTNS

Use of investigational drug/device therapy within the past 4 weeks

Participating or have participated within the past 4 weeks in any clinical investigation involving or impacting gynecologic, urinary or renal function

Deemed unsuitable for enrollment in study by the investigators based on subjects' history or physical examination

The patient has metal implant from surgery or a metallic foreign body in either leg below (distal to) the knee (or permanent metallic tattoo <30cm from left ankle).

The patient has chronic constipation (less than two (2) bowel movements per week)

The patient has history of gastric or urinary retention

The patient has uncontrolled diabetes

Subjects with nerve damage, injury or surgery that would impact either tibial nerve or pelvic floor function

The patient is unable or unwilling to sign informed consent

The patient is currently on pharmacologic treatment that could affect bladder function

Known Cystocele >/= to Grade 3 that has not been reduced by treatment (surgery or pessary)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01214265